Generation 4 Polished Femoral Hip Prosthesis with Proximal Cement Spacer

Q: What is the product code of K052639?

The FDA product code is JDI – Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented, a Class II (moderate risk) device regulated under 21 CFR 888.3350.

FDA 510(k) K052639 · Biomet Manufacturing, Inc.

Substantially Equivalent

510(k) numberK052639

Submission

Device name: Generation 4 Polished Femoral Hip Prosthesis with Proximal Cement Spacer
Applicant: Biomet Manufacturing, Inc.
Warsaw, IN, US
Received: September 26, 2005
Decision date: May 3, 2006
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: JDI – Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Device class: Class II (moderate risk)
Regulation: 21 CFR 888.3350
Specialty: Orthopedic
Implant: Yes

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Questions and answers

When was Generation 4 Polished Femoral Hip Prosthesis with Proximal Cement Spacer cleared by the FDA?

Generation 4 Polished Femoral Hip Prosthesis with Proximal Cement Spacer (K052639) received a 510(k) decision of Substantially Equivalent on May 3, 2006, 219 days after the submission was received.

What is the product code of K052639?

The FDA product code is JDI – Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented, a Class II (moderate risk) device regulated under 21 CFR 888.3350.